Thrombus removal device and system

• US 8,771,289 B2
• Filed: 12/21/2009
• Issued: 07/08/2014
• Est. Priority Date: 12/21/2009
• Status: Active Grant

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Inventors: Mohiuddin, Khader, Wilson, Robert F.
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): TANNER, JOCELIN C
• Application Number:
  US12/643,499
• Publication Number:
  US 20110152823A1
• Time in Patent Office: 1,660 Days
• Field of Search: 600/585, 600/125, 600/124, 600/106, 600/104, 606110-115, 606/127, 606/128, 606/194, 606/200, 606/198, 606/192, 606/170, 606/159, 604/523, 604/104, 604/528, 604/107, 604/22, 604/103.01, 604/118, 604/124, 604/125, 604/131, 604/134, 604/173, 604/171, 604/176, 604/192, 604/164.08, 604/164.09, 604/164.13, 604/35, 604/508, 604/509, 604/507
• US Class Current: 606/127
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/005 with suction drainage system

Abstract

Devices and methods for removing a thrombus (clot) from a vascular structure of a living subject. An embodiment of a thrombus removal device comprises first and second annular members, the first annular member being adapted to slide over a guidewire placed in a vascular structure, the second annular member being coupled to the first annular member and having a suction flow path therethrough, the first annular member having an expandable mesh structure disposed at a distal portion thereof, the mesh structure being deployable to an expanded configuration by movement of an actuating element extending along the second annular member. An embodiment of a thrombus removal method comprises advancing the device to position the mesh structure downstream of the thrombus by sliding the first annular member over the guidewire, applying a suction force to the suction flow path of the second annular member, deploying the mesh structure, and retracting the device to cause the mesh structure to engage the thrombus.

Claims

1. A device for removing a thrombus from a vascular structure, the device comprising:

a first annular member having a guidewire lumen for slidably receiving a guidewire;

a second annular member coupled to the first annular member, the second annular member adapted to provide a suction flow path from a suction port in a distal portion of the second annular member to a proximal portion of the second annular member, the distal portion of the second annular member being directly coupled to a proximal portion of the first annular member;

a flexible mesh structure coupled to an outer surface of a distal portion of the first annular member,

the suction port of the second annular member positioned to be in direct fluid communication with the vascular structure proximal of the flexible mesh structure, a longitudinal axis of the second annular member intersecting the suction port, and

an actuating element coupled to the flexible mesh structure, the actuating element extending externally of the first annular member from the mesh structure to the distal portion of the second annular member and extending on to the proximal portion of the second annular member, the actuating element adapted to deploy the flexible mesh structure to an expanded configuration in response to movement of the actuating element with respect to the second annular member.

2. The device of claim 1 wherein the flexible mesh structure comprises a nitinol mesh.

3. The device of claim 1 wherein the flexible mesh structure has a mesh pattern which can capture particles of a clinically significant size.

4. The device of claim 3 wherein the flexible mesh structure has a denser mesh pattern near a distal end of the mesh structure.

5. The device of claim 1 wherein the flexible mesh structure is substantially annular, having a proximal end, a distal end, and a middle portion, the middle portion being adapted to expand radially outward to the expanded configuration when the proximal and distal ends are positioned more closely together.

6. The device of claim 5 wherein the middle portion of the mesh structure is adapted to conform to the first annular member when the flexible mesh structure is in an unexpanded configuration.

7. The device of claim 5 wherein the proximal end of the mesh structure is connected to the first annular member, and the distal end of the mesh structure is slidably coupled to the first annular member.

8. The device of claim 7 wherein the actuating element is coupled to the distal end of the mesh structure.

9. The device of claim 7 wherein the mesh structure further comprises a slider at the distal end of the mesh structure, the slider adapted to slide over the distal portion of the first annular member.

10. The device of claim 9 wherein the actuating element is coupled to the slider.

11. The device of claim 5 wherein the distal end of the mesh structure is connected to the first annular member, and the proximal end of the mesh structure is slidably coupled to the first annular member.

12. The device of claim 1 wherein the suction port comprises an opening in a distal end of the second annular member.

13. The device of claim 1 further comprising one or more openings in a sidewall of the distal portion of the second annular member.

14. The device of claim 1 wherein the second annular member is adapted to advance the first annular member over the guidewire to position the flexible mesh structure near a thrombus.

15. The device of claim 1 wherein the proximal portion of the second annular member comprises a connection for coupling a suction source to the suction flow path.

16. The device of claim 15 wherein the suction source comprises a syringe.

17. The device of claim 15 wherein the suction source comprises a vacuum.

18. The device of claim 1 wherein the proximal portion of the second annular member comprises a handle for moving the actuating element.

19. The device of claim 18 wherein the handle is adapted to rotate to move the actuating element longitudinally.

20. The device of claim 18 wherein the handle further comprises a locking mechanism adapted to maintain the mesh structure in either an expanded configuration or an unexpanded configuration.

21. The device of claim 18 wherein the handle is adapted to move the actuating element proximally or distally.

22. The device of claim 21 wherein the handle comprises a spring-loaded trigger.

23. The device of claim 1 wherein the second annular member comprises a polyimide tube.

24. The device of claim 1 wherein the second annular member is formed of a thermoplastic elastomer.

25. The device of claim 24 wherein the second annular member is formed of nylon-12.

26. The device of claim 1 wherein the second annular member is between about 40 and 200 centimeters in length.

27. The device of claim 1 wherein the first annular member comprises a polyimide tube.

28. The device of claim 1 wherein the first annular member is between about 5 and 30 centimeters in length.

29. The device of claim 1 wherein the first annular member is coupled to the second annular member in a substantially parallel arrangement.

30. The device of claim 29 wherein the first annular member is coupled to an outer surface of the second annular member.

31. The device of claim 29 wherein the first annular member is coupled to an inner surface of the second annular member.

32. The device of claim 31 wherein the first annular member is substantially concentric within the second annular member.

33. The device of claim 31 wherein an outer surface of the first annular member is coupled directly to an inner surface of the second annular member.

34. The device of claim 1 wherein the actuating element is disposed within the suction flow path.